Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications

Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients with Type 2 Diabetes - SAVOR

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017358-10-HU

Enrollment

16500

Registered

2010-02-15

Start date

2010-03-26

Completion date

Unknown

Last updated

2013-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: Saxagliptin Product Code: BMS-477118-11 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Saxagliptin CAS Number: 945667-22-1 Current Sponsor code: BMS-477118-11 Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes mellitus HbA1c =6.5%. (based on the last measured and documented laboratory measurement within 6 months) High risk for CV events -Established cardiovascular disease and/or multiple risk factors Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range ;Inclusion criteria: Patients with type 2 diabetes mellitus HbA1c =6.5%. (based on the last measured and documented laboratory measurement within 6 months) High risk for CV events -Established cardiovascular disease and/or multiple risk factors Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics Acute vascular event <2months prior to randomisation ;Exclusion criteria: Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics Acute vascular event <2months prior to randomisation

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary efficacy objective is to determine, as a superiority assessment, whether treatment with saxagliptin compared with placebo when added to current background therapy will result in a reduction in the composite endpoint of CV death, non-fatal MI or non-fatal ischaemic stroke in patients with T2DM. The primary safety objective is to establish that the upper bound of the 2-sided 95% CI for the estimated risk ratio comparing the incidence of the composite endpoint of CV death, non-fatal MI or non-fatal ischaemic stroke in patients with T2DM observed with saxagliptin to that observed in the placebo group is less than 1.3.;Secondary Objective: The first secondary efficacy objective is to determine whether treatment with saxagliptin compared with placebo when added to current background therapy in patients with T2DM will result in a reduction of the composite endpoint of CV death, non-fatal MI, non-fatal ischaemic stroke, hospitalisation for heart failure, hospitalisation for unstable angina pectoris or hospitalisation for coronary revascularisation. The next secondary efficacy objective is to determine whether treatment with saxagliptin compared with placebo when added to current background therapy in patients with type 2 diabetes mellitus will result in a reduction of all-cause mortality.;Primary end point(s): The primary efficacy and safety outcome variable of the study is defined as the composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischaemic stroke (time to first event). ;Timepoint(s) of evaluation of this end point: End of study, once 1040 Major adverse cardiovascular events (MACE) events are accrued;Main Objective: The primary efficacy objective is to determine, as a superiority assessment, whether treatment with saxagliptin compared with placebo when added to current background therapy will result in a reduction in the composite endpoint of CV death, non-fatal MI or non-fatal ischaemic stroke in p	—

Measure

Time frame

Main Objective: The primary efficacy objective is to determine, as a superiority assessment, whether treatment with saxagliptin compared with placebo when added to current background therapy will result in a reduction in the composite endpoint of CV death, non-fatal MI or non-fatal ischaemic stroke in patients with T2DM. The primary safety objective is to establish that the upper bound of the 2-sided 95% CI for the estimated risk ratio comparing the incidence of the composite endpoint of CV death, non-fatal MI or non-fatal ischaemic stroke in patients with T2DM observed with saxagliptin to that observed in the placebo group is less than 1.3.;Secondary Objective: The first secondary efficacy objective is to determine whether treatment with saxagliptin compared with placebo when added to current background therapy in patients with T2DM will result in a reduction of the composite endpoint of CV death, non-fatal MI, non-fatal ischaemic stroke, hospitalisation for heart failure, hospitalisation for unstable angina pectoris or hospitalisation for coronary revascularisation. The next secondary efficacy objective is to determine whether treatment with saxagliptin compared with placebo when added to current background therapy in patients with type 2 diabetes mellitus will result in a reduction of all-cause mortality.;Primary end point(s): The primary efficacy and safety outcome variable of the study is defined as the composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischaemic stroke (time to first event). ;Timepoint(s) of evaluation of this end point: End of study, once 1040 Major adverse cardiovascular events (MACE) events are accrued;Main Objective: The primary efficacy objective is to determine, as a superiority assessment, whether treatment with saxagliptin compared with placebo when added to current background therapy will result in a reduction in the composite endpoint of CV death, non-fatal MI or non-fatal ischaemic stroke in p

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Secondary

Measure	Time frame
Secondary end point(s): The secondary efficacy variable is the composite endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal ischaemic stroke, hospitalisation for heart failure, hospitalisation for unstable angina pectoris or hospitalisation for coronary revascularisation. ;Timepoint(s) of evaluation of this end point: End of study, once 1040 Major adverse cardiovascular events (MACE) events are accrued;Secondary end point(s): The secondary efficacy variable is the composite endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal ischaemic stroke, hospitalisation for heart failure, hospitalisation for unstable angina pectoris or hospitalisation for coronary revascularisation. ;Timepoint(s) of evaluation of this end point: End of study, once 1040 Major adverse cardiovascular events (MACE) events are accrued	—

Measure

Time frame

Secondary end point(s): The secondary efficacy variable is the composite endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal ischaemic stroke, hospitalisation for heart failure, hospitalisation for unstable angina pectoris or hospitalisation for coronary revascularisation. ;Timepoint(s) of evaluation of this end point: End of study, once 1040 Major adverse cardiovascular events (MACE) events are accrued;Secondary end point(s): The secondary efficacy variable is the composite endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal ischaemic stroke, hospitalisation for heart failure, hospitalisation for unstable angina pectoris or hospitalisation for coronary revascularisation. ;Timepoint(s) of evaluation of this end point: End of study, once 1040 Major adverse cardiovascular events (MACE) events are accrued

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Countries

Argentina, Australia, Brazil, Canada, Chile, China, Czech Republic, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Mexico, Netherlands, Peru, Poland, Russian Federation, South Africa, Spain, Sweden, Taiwan, Thailand, United Kingdom, United States

Contacts

Public ContactInformation Centre;Information Centre ;

AstraZeneca;AstraZeneca

information.center@astrazeneca.com;information.center@astrazeneca.com;

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026